(89 days)
The CoolTouch CT3S Nd:YAG Laser System is indicated:
a) for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue,
b) for use in the treatment of fine lines and wrinkles,
c) for treatment of back acne and atrophic acne scars,
d) for treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities.
The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, and/or the handpiece.
The provided text is a 510(k) summary for the CoolTouch Corporation Model CT3S Nd:YAG Laser System. It focuses on regulatory approval and device specifications rather than detailed clinical study data with specific acceptance criteria and performance metrics typically found in clinical trial reports.
Therefore, many of the requested sections about acceptance criteria, detailed study design, and ground truth establishment cannot be fully answered from the provided document. The document explicitly states "Non-clinical Performance Data: None" and for clinical data refers to "previous related 510(k) submissions."
Acceptance Criteria and Study Information for CoolTouch CT3S Nd:YAG Laser System
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not specify quantitative acceptance criteria or detailed performance metrics from a specific study for the CoolTouch CT3S Nd:YAG Laser System. The clinical performance section states:
- "Clinical trials also produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of reflux of the greater saphenous vein associated with varicose veins and varicosities. See previous related 510(k) submissions for clinical results."
This statement confirms that clinical trials were conducted and supported effectiveness, but the specific performance results or acceptance criteria are not included in this document. The 510(k) process primarily demonstrates substantial equivalence to a predicate device, which may not require new, full-scale clinical trials if sufficient prior data or a clear technological equivalence exists.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The document refers to "previous related 510(k) submissions for clinical results," implying the data was drawn from prior studies, but details about sample size, country of origin, or retrospective/prospective nature are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the given 510(k) summary. Given the nature of a laser system for surgical and dermatological applications, ground truth would likely involve clinical assessment by qualified medical professionals (e.g., dermatologists, vascular surgeons), but specifics are not mentioned here.
4. Adjudication Method for the Test Set
This information is not provided in the given 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided in the given 510(k) summary. This type of study is more common for diagnostic AI systems evaluating image interpretation, which doesn't directly apply to a laser surgical device in the same way.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided in the given 510(k) summary. The CoolTouch Nd:YAG Laser System is a physical medical device, not an algorithm, and its operation inherently involves a human operator (a clinician). Therefore, a "standalone algorithm only" performance study is not relevant to this device.
7. The Type of Ground Truth Used
The document refers to "clinical trials" demonstrating effectiveness, particularly for treating reflux of the greater saphenous vein. This strongly suggests that the ground truth would have been based on clinical outcomes data (e.g., successful vein closure, reduction in varicose veins, improvement in cosmetic appearance for skin treatments) as assessed by clinicians. However, the specific methodology for establishing this ground truth (e.g., objective measurements, physician assessment scales, imaging confirmation) is not detailed in this summary.
8. The Sample Size for the Training Set
This information is not provided in the given 510(k) summary. As this is not an AI/machine learning device, the concept of a "training set" in the context of data for model development does not apply in the typical sense. Data from previous clinical trials would inform the device's design and demonstrate its safety and effectiveness, but it wouldn't be a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided in the given 510(k) summary, as it pertains to an AI/machine learning context which does not apply to this device. Clinical data from prior studies (as referenced) would have established their respective ground truths based on clinical assessments and outcomes.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.